DCGI grants marketing authorization to SII’s qHPV vaccine against cervical cancer

drug controller general India (DCGI) on Tuesday granted market permission to Serum Institute of India (SII) to manufacture India’s first indigenously developed quadrivalent Human Papillomavirus Vaccine (qHPV) against cervical cancer, official sources said.

DCGI’s approval comes after the recommendation of the Subject Expert Committee (SEC) on COVID-19 of CDSCO on June 15 on the same. Prakash Kumar Singh, Director (Government and Regulatory Affairs) at Serum Institute had applied to DCGI seeking market authorization of QHPV with the support of Department of Biotechnology to ensure its early availability after Phase 2/3 clinical trials , said the official source.

The government advisory panel NTAGI recently approved qHPV after reviewing clinical trial data for the vaccine. In the application to DCGI, Singh has stated that the qHPV vaccine CERVAVAC has demonstrated robust antibody response that is approximately 1,000-fold higher across all targeted HPV types and across all doses and age groups.

In the application, Singh had mentioned that every year lakhs of women are diagnosed with cervical cancer as well as some other cancers and the death ratio is also very high. Cervical cancer in India is the second most common cancer among women aged 15 to 44 years.

“It is also worth mentioning that at present our country is completely dependent on foreign manufacturers for HPV vaccine. In line with the philosophy of our group and under the leadership of our CEO, Dr Adar C Poonawalla, it has always been our endeavor to provide high quality ‘Made in India’ vaccines at affordable cost to the people of our country and the world, Singh said. mentioned in the application.

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